Product code DRG— Cardiovascular
ANNE One
- Advisory panel
- Cardiovascular
- Total cleared
- 192
Adverse events under product code DRG
product code DRG- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DRG
1–100 of 192- K261569 — UbiqVue 2AYe Cardiac System (UX2253)
- K252984 — Perin Health System (PHD80060-2)
- K252440 — EasyTeleMed (2.0.2)
- K250259 — TeleRehab Aermos Cardiopulmonary Rehabilitation
- K243837 — iBSM
- K242018 — UbiqVue 2A Multi-parameter System (UX2550)
- K241101 — BioButton System
- K240251 — ANNE Chest
- K223711 — ANNE One
- K220526 — HD+12, HD+15
- K223073 — Alio
- K222398 — Care Team Portal
- K212957 — BioButton System
- K221530 — ANNE Pediatric
- K212883 — ers2 - ergoline Rehabilitation System
- K213233 — EZYPRO ECG Recorder (Model: UG02)
- K211365 — Alio Medical Remote Monitoring System
- K211822 — LifePath Remote Patient Monitoring Platform
- K211305 — ANNE One
- K202868 — LifeSignals Multi-Parameter Remote Monitoring Platform
- K200690 — LifeSignals ECG Remote Monitoring Patch Platform
- K191620 — Vitls Platform
- K193343 — Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)
- K192875 — Philips Biosensor BX100
- K192757 — VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of 20, VitalPatch 7D Biosensor bag of 20
- K191870 — VV330 Continuous ECG Platform, VivaLNK Adhesive Patch
- K191614 — BioSticker System
- K191331 — Life Sensor Cardiac Monitor
- K190916 — VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20
- K183078 — VitalConnect Platform, VitalPatch Biosensor
- K182297 — Surveyor S2
- K181248 — Comarch e-Care Platform
- K181196 — Caretaker Remote Display App and Caretaker Software Library
- K172011 — LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)
- K171019 — ScioCardio ECG Transmitter
- K173510 — BioStamp nPoint
- K172329 — Patient Status Engine
- K163694 — Rooti Rx ECG Event Recorder, Rooti Link APP Software
- K163453 — VitalPatch® VitalConnect Platform
- K171406 — Optum TeleHealth Application
- K171029 — eCareCoordinator
- K171188 — Ossler Exam Scope
- K170973 — VitalWatch Software User Interface
- K170204 — FFR Link, FFR Signal Processing Module
- K161916 — TelePatch Cardiac Monitor
- K153719 — LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream
- K152139 — Vital Connect Platform, HealthPatch MD, VitalPatch
- K150289 — CARDIOLINE HD+
- K141020 — SURVEYOR S4 MOBILE MONITOR
- K141792 — GENESIS TOUCH SYSTEM
- K133997 — LG SMARTHEALTH
- K141706 — ECARE COORDINATOR (ECC)
- K141167 — VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)
- K132173 — FAMILY HEALTHWARE
- K132930 — MYHEALTHPOINT TELEHEALTH MANAGER
- K132447 — VITALCONNECT PLATFORM BY VITAL CONNECT INC.
- K133252 — HEALTHINTERLINK BEACON
- K134004 — VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE
- K133587 — PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300
- K132803 — MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK
- K132148 — S HEALTH
- K131913 — INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC
- K130971 — OPTUM TELEHEALTH APPLICATION
- K130821 — INTEL-GE CARE INNOVATIONS CONNECT RCM
- K122458 — VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM
- K124000 — MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM
- K130360 — CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION
- K130676 — AMBIO REMOTE HEALTH MONITORING SYSTEM
- K122763 — PHYSIOLOGICAL DATA PROCESSOR
- K130290 — MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE
- K123671 — WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM
- K123229 — REMOTE PRESENCE SYSTEM, MODEL RP-VITA
- K122333 — MOBILECARE MONITOR
- K122285 — TABLET COMMANDER
- K122095 — ICP TRIAGEMANAGER
- K120325 — CONNECTED CARE MOBILE APPLICATION
- K113446 — VIGNET TELEHEALTH MANAGER
- K120253 — ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)
- K120941 — CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM
- K120470 — MIPAL
- K120895 — REMOTE PRESENCE SYSTEM
- K120704 — 3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM
- K112858 — GENESIS TOUCH SYSTEM
- K113493 — TCX-I REMOTE CARE MANAGEMENT SYSTEM
- K111922 — VOCARE MYHEALTH TABLET
- K112559 — MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM
- K111854 — AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER
- K103643 — ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)
- K103796 — TELEMEDCARE HEALTH MONITOR
- K110809 — WIRELESS MONITORING SYSTEM
- K110334 — WALDO PATIENT MONITOR
- K103276 — INTEL HEALTH GUIDE
- K102106 — NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION
- K103214 — M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130
- K101834 — 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM
- K101178 — MODIFICATION TO INTEL HEALTH GUIDE PHS6000
- K101242 — GENESIS DM MODEL: 6053000A1
- K100427 — FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY
- K100524 — POLYTEL(R) APT MODEL: PWA-08-01
- K093895 — ALLY PLATFORM SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.